Errata - English

In Light-resistant container: Change
〈661.2〉, Functionality, Spectral Transmission Requirements for Light-Resistant Components and Systems.
to:
〈661.2〉, Functionality Test Method, Spectral Transmission Requirements for Light-Resistant Components and Systems.

In Analysis: Change
^▲Add 1 mL of silver nitrate TS to the Standard solution and then add a 50-mL portion of the Sample solution. Mix and allow to stand for 5 min protected from direct sunlight. Compare the turbidity of the solutions._{▲(NF 1-May-2019)}
to:
Add 1 mL of silver nitrate TS to the Standard solution. Add 1 mL of silver nitrate TS to a 50-mL portion of the Sample solution. After mixing, allow each solution to stand for 5 min protected from direct sunlight. Compare the turbidity of the solutions.

In Tolerances: Change
NLT 75 (Q) of the labeled amount of sorafenib (C₂₁H₁₆ClF₃N₄O₃) is dissolved.
to:
NLT 75% (Q) of the labeled amount of sorafenib (C₂₁H₁₆ClF₃N₄O₃) is dissolved.

In USP Tryptophan Related Compound A RS: Change
3,3′-[Ethylidenebis(1H-indole-1,3-diyl)]bis[2S)-2-aminopropanoic]acid.
C₂₄H₂₆N₄O₄ 432.49
to:
(2S,2'S)-3,3'-[Ethane-1,1-diylbis(1H-indole-1,3-diyl)]bis(2-aminopropanoic acid).
C₂₄H₂₆N₄O₄ 434.50

Change
USP Atorvastatin Related Compound H RS (lactone impurity)
to:
USP Atorvastatin Related Compound H RS
Also known as Lactone impurity;
AND
Change
USP Atorvastatin Related Compound I RS (acetonide impurity)
to:
USP Atorvastatin Related Compound I RS
Also known as Acetonide impurity;

In Dissolution 〈711〉/Test for dutasteride/Tier 2/Medium: Change
10 g/L of cetyltrimethylammonium bromide and 750,000 USP units of activity/mg of pepsin, purified in 0.1 N hydrochloric acid; 900 mL
to:
Dissolve 10 g of cetyltrimethylammonium bromide and 1.6 g of pepsin, purified in 1000 mL of 0.1 N hydrochloric acid; 900 mL

In Peptone diluent: Change
Dispense into sterile containers as needed for preparing samples. Trace mineral solution. Prepare a solution containing
to:
Dispense into sterile containers as needed for preparing samples.
Trace mineral solution: Prepare a solution containing

In Acceptance criteria/Total impurities: Change
NMT 2.5%. Disregard any peak below 0.05% of the peak area of fluocinolone acetonide from the Standard solution.
to:
NMT 2.5%. Disregard any peak below 0.05% of the peak area of fluocinolone acetonide from the Sample solution.

Change
Where the label states tetracycline hydrochloride must be subjected to further processing during the preparation of injectable dosage forms, the level of bacterial endotoxins are such that the requirement under the relevant dosage form monograph(s) in which tetracycline hydrochloride is used can be met.
to:
Where the label states Tetracycline Hydrochloride must be subjected to further processing during the preparation of injectable dosage forms, the level of bacterial endotoxins are such that the requirement under the relevant dosage form monograph(s) in which Tetracycline Hydrochloride is used can be met.

In Analysis: Change
r_A = peak response of each saccharide degree of polymerization (DP₁–DP₃) in the Sample solution (If any peaks of DP₄ and above are observed in the sample, take the summation of all peak responses DP₄₊ and use this value as r_U.)
to:
r_A = peak response of each saccharide degree of polymerization (DP₁–DP₃) in the Sample solution (If any peaks of DP₄ and above are observed in the sample, take the summation of all peak responses DP₄₊ and use this value as r_A.)

Change
Homogenize 1 Capsule in 3 mL of water, add 3 mL of methanol, and centrifuge: the supernatant so obtained meets the requirements of the test for Radiochemical purity under Sodium Iodide I 123 Solution.
to:
Place a measured volume of a solution, containing 100 mg of potassium iodide, 200 mg of potassium iodate, and 1 g of sodium bicarbonate in each 100 mL, 25 mm from one end of a 25- × 300-mm strip of chromatographic paper (see Chromatography <621>), and allow to dry. To the same area add a similar volume of the sample solution prepared as follows: homogenize the content from 1 Capsule in 3 mL of water and 3 mL of methanol and centrifuge. The supernatant should be diluted so that it provides a count rate of about 20,000 counts per minute. Allow the spots to dry. Develop the chromatogram over a period of about 4 hours by ascending chromatography, using dilute methanol (7 in 10). Dry the chromatogram in air, and determine the radioactivity distribution by scanning with a suitable collimated radiation detector: the radioactivity of the iodide ¹²³I band is not less than 95.0% of the total radioactivity, and its R_F value falls within ±5.0% of the value found for sodium iodide when determined under similar conditions. Confirmation of the identity of the iodide band is made by the addition to the suspected iodide band of 6 drops of acidified hydrogen peroxide solution (prepared by adding 6 drops of 1 N hydrochloric acid to 10 mL of hydrogen peroxide solution) followed by the dropwise addition of starch TS: the development of a blue color indicates the presence of iodide.

In A./Standard solution B: Change
USP Procyanidin A₂ RS
to:
USP Procyanidin A2 RS
AND
In A./System suitability/Suitability requirements/Derivatization reagent B/White light: Change
Standard solution B exhibits two brown bands in the upper-half section corresponding to procyanidin A₂ and epicatechin. Standard solution C exhibits two brown bands in the upper-half section corresponding in R_F and color to procyanidin A₂ and epicatechin in Standard solution B. Standard solution C also exhibits a series of faint or indistinct brown bands of differing intensities below procyanidin A₂ in the lower-half section.
to:
Standard solution B exhibits two brown bands in the upper-half section corresponding to procyanidin A2 and epicatechin. Standard solution C exhibits two brown bands in the upper-half section corresponding in R_F and color to procyanidin A2 and epicatechin in Standard solution B. Standard solution C also exhibits a series of faint or indistinct brown bands of differing intensities below procyanidin A2 in the lower-half section.
AND
In A./Acceptance criteria/Derivatization reagent B/White light: Change
The Sample solution exhibits two faint brown bands corresponding in R_F to procyanidin A₂ and epicatechin in Standard solution B. The Sample solution also exhibits a series of faint or indistinct brown bands of differing intensities in the lower-half section, corresponding to the same bands in Standard solution C. No bands corresponding in R_F to epigallocatechin-3-O-gallate, procyanidin B₂, or procyanidin B₁ appear below procyanidin A₂.
to:
The Sample solution exhibits two faint brown bands corresponding in R_F to procyanidin A2 and epicatechin in Standard solution B. The Sample solution also exhibits a series of faint or indistinct brown bands of differing intensities in the lower-half section, corresponding to the same bands in Standard solution C. No bands corresponding in R_F to epigallocatechin-3-O-gallate, procyanidin B2, or procyanidin B1 appear below procyanidin A2.
AND
In C./Acceptance criteria/Profile at 520 nm: Change
cyanidin-3-O-arabinose,
to:
cyanidin-3-O-arabinoside,
AND
In C./Acceptance criteria/Profile at 520 nm: Change
peonidin-3-O-arabinose
to:
peonidin-3-O-arabinoside

In USP Lansoprazole Related Compound B RS: Change
2-[[[3-Methyl-4-(2,2,2-trifluoroethoxy)-pyridin-2-yl] methyl]sulfanyl]-1H-benzimidazole.
C₁₆H₁₄F₃N₃OS 353.36
to:
2-{[(3-Methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl)methyl]thio}benzimidazole monohydrate.
C₁₆H₁₄F₃N₃OS · H₂O 371.38

Change
Sample solution: 0.12 mg/mL of Mercaptopurine in Solution A. [NOTE—Inject the Sample solution within 1 h of preparation.]
to:
Sample stock solution: 0.5 mg/mL of mercaptopurine in a mixture of methanol and Solution A (1:9) prepared as follows. Transfer a suitable quantity of Mercaptopurine to an appropriate volumetric flask, add methanol equivalent to 10% of the final volume, and shake to dissolve. Dilute with Solution A to volume.
Sample solution: 0.12 mg/mL of mercaptopurine in Solution A from the Sample stock solution. [NOTE—Inject the Sample solution within 1 h of preparation.]

In USP Succinylmonocholine Chloride RS: Change
Ethanaminium, 2-(carboxy-1-oxopropoxy)-N,N,N-trimethyl-, chloride.
to:
Ethanaminium, 2-(3-carboxy-1-oxopropoxy)-N,N,N-trimethyl-, chloride;
Also known as 2-[(3-Carboxypropanoyl)oxy]-N,N,N-trimethylethan-1-aminium chloride.

In B: Change
It meets the requirements in the test Viscosity—Capillary Methods <911>, Viscosity—Rotational Methods <912>, and Viscosity—Rolling Ball Method <913>.
to:
It meets the requirements in the test Viscosity—Capillary Methods <911>, Viscosity—Rotational Methods <912>, or Viscosity—Rolling Ball Method <913>.

Change
2-(2-Carboxyethyl)-1,2,3,4-tetrahydro-6,7-dimeth oxy-2-methyl-1-veratrylisoquinolinium benzenesulfonate, pentamethylene ester
to:
2-(2-Carboxyethyl)-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methyl-1-veratrylisoquinolinium benzenesulfonate, pentamethylene ester

In Analysis: Change
C_S = concentration of the corresponding USP Doxazosin Related Compound RS or USP Doxazosin Mesylate RS (for calculating unspecified impurities) in the Standard solution (mg/mL)
to:
C_S = concentration of the corresponding USP Reference Standard or USP Doxazosin Mesylate RS (for calculating unspecified impurities) in the Standard solution (mg/mL)

In USP Mirtazapine Resolution Mixture RS: Change
Impurity D: 1,2,3,4,10,14b-Hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepine.
to:
Impurity D: [Note–This impurity may be available either as the free base form or as the hydrochloride salt form.] 1,2,3,4,10,14b-Hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepine or 1,2,3,4,10,14b-Hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepine hydrochloride.

In USP Cetirizine Related Compound A RS: Change
2-(2-{4-[(4-Chlorophenyl)phenylmethyl]piperazin-1-yl}ethoxy)acetic acid, ethyl ester dihydrochloride.
C₂₃H₂₉ClN₂O₃ · 2HCl 489.86
to:
(RS)-2-[2-[4-[(4-Chlorophenyl)phenylmethyl]piperazin-1-yl]ethoxy]acetic acid ethyl ester oxalate.
C₂₃H₂₉ClN₂O₃ · C₂H₂O₄ 506.98

In USP Pantoprazole Related Compound E RS: Change
A mixture of the stereoisomers of 6,6′-bis(difluoromethoxy)-2,2′-bis[[(3,4-dimethoxypyridin-2-yl)methyl]sulfinyl]-1H,1′H-5,5′-bibenzimidazolyl.
to:
6,6′-Bis(difluoromethoxy)-2,2′-bis[[(3,4-dimethoxypyridin-2-yl)methyl]sulfinyl]-1H,1′H-5,5′-bibenzimidazole.

In USP Fexofenadine Related Compound A RS: Change
Benzeneacetic acid, 4-[1-oxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethyl.
C₃₂H₃₇NO₄ 538.12
to:
2-(4-{4-[4-(Hydroxydiphenylmethyl)piperidin-1-yl]butanoyl}phenyl)-2-methylpropanoic acid;
Also known as Benzeneacetic acid, 4-[1-oxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethyl.
C₃₂H₃₇NO₄ 499.65

In Analysis: Change
r_S = sum of all the peaks except those each of which with an area less than 0.1 times the area of the major peak from the Reference solution
to:
r_T = sum of all the peaks except those each of which with an area less than 0.1 times the area of the major peak from the Reference solution

In Procedure: Change
(694.83/676.83)(25)C_A(r_U/r_S)
in which 694.83 and 676.83 are the molecular weights of atropine sulfate monohydrate and anhydrous atropine sulfate, respectively;
to:
(694.84/676.82)(25)C_A(r_U/r_S)
in which 694.84 and 676.82 are the molecular weights of atropine sulfate monohydrate and anhydrous atropine sulfate, respectively;

In Analysis: Change
M_r1 = molecular weight of atorvastatin, 558.64
M_r2 = molecular weight of atorvastatin calcium, 1155.34
to:
M_r1 = molecular weight of atorvastatin, 558.65
M_r2 = molecular weight of atorvastatin calcium, 1155.36

In USP Carvedilol Related Compound A RS: Change
629.74
to:
629.75
AND
In USP Carvedilol Related Compound B RS: Change
645.74
to:
645.76
AND
In USP Carvedilol Related Compound C RS: Change
496.60
to:
496.61
AND
In USP Carvedilol Related Compound E RS: Change
2-(2-Methoxyphenoxy)ethyl amine.
C₉H₁₃NO₂ 167.21
to:
[Note—This material may be available in the free base or salt form.]
2-(2-Methoxyphenoxy)ethyl amine.
C₉H₁₃NO₂ 167.21
2-(2-Methoxyphenoxy)ethyl amine hydrochloride monohydrate.
C₉H₁₃NO₂ ∙ HCl ∙ H₂O 221.68
AND
In USP Carvedilol System Suitability Mixture RS: Change
Mixture of approximately 0.1% carvedilol related compound F (1-(2-(2-Methoxyphenoxy)ethylamino)-3-(2,3,4,9-tetrahydro-1H-carbazol-5-yloxy)propan-2-ol) in a matrix of carvedilol drug substance.
to:
Contains a mixture of carvedilol related compound F in a matrix of carvedilol drug substance:
Carvedilol.
Carvedilol related compound F.
[Note—This material may be available in the free base or salt form.]
1-(2-(2-Methoxyphenoxy)ethylamino)-3-(2,3,4,9-tetrahydro-1H-carbazol-5-yloxy)propan-2-ol.
C₂₄H₃₀N₂O₄ 410.51
1-(2-(2-Methoxyphenoxy)ethylamino)-3-(2,3,4,9-tetrahydro-1H-carbazol-5-yloxy)propan-2-ol acetate.
C₂₄H₃₀N₂O₄ ∙ C₂H₄O₂ 470.57